Juno VPAP ST-A

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 19, 2017 Resmed Ltd % Larissa D'Andrea Director, Government & Regulatory Affairs Resmed Corp. 9001 Spectrum Center Boulevard San Diego, California 92123 Re: K161492 Trade/Device Name: Juno VPAP ST-A Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: MNS Dated: December 16, 2016 Received: December 19, 2016 Dear Larissa D'Andrea: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Tina Kiang, Ph. D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K161492 Device Name Juno VPAP ST-A Indications for Use (Describe) The Juno VPAP ST-A is indicated to provide noninvasive ventilation for patients weighing more than 30lbs (13 kg) with respiratory insufficiency or obstructive sleep apnoea (OSA). The iVAPS mode is indicated for patients weighing more than 66lbs (30 kg). The Juno VPAP ST-A is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for ResMed. The logo consists of a series of blue and red dots arranged in a curved line, resembling a sine wave. Below the dots, the word "ResMed" is written in a bold, sans-serif font. # 510(k) SUMMARY [As required by 21 CFR 807.92(c)] - 1. Date prepared January 13, 2017 ## 2. Applicant information | Company Name/<br>Owner | ResMed Ltd<br>1 Elizabeth Macarthur Drive<br>Bella Vista NSW 2153 Australia | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Name | Mr. Jean-Nicolas Boudaud<br>Regulatory Affairs Manager<br>+61 2 88841000 (phone)<br>+61 2 88842004 (fax)<br>Jean.boudaud@resmed.com.au | | Correspondent Details/<br>Official Contact | Ms. Larissa D'Andrea<br>Director, Government & Regulatory Affairs<br>9001 Spectrum Center Blvd<br>San Diego CA 92123 USA<br>(858) 836 6837 (phone)<br>Larissa.D'Andrea@resmed.com<br><br>Mr. Jean-Nicolas Boudaud<br>Regulatory Affairs Manager<br>+61 2 88841000 (phone)<br>+61 2 88842004 (fax)<br>Jean.boudaud@resmed.com.au | #### 3. Device details and substantial equivalence claim [807.92(a)(3)] | Trade/Device Names | Juno VPAP ST-A | |--------------------|-----------------------------------------------| | Device Common Name | Ventilator, continuous, non-life supporting | | Regulation Number | 21 CFR §868.5895 | | Regulation Name | Anesthesiology devices, Continuous Ventilator | | Regulatory Class | Class II | | Product Code | MNS | | Predicate Device | ResMed Juno VPAP ST-A (K153061) | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for ResMed. The logo consists of the word "ResMed" in bold, sans-serif font. Above the word is a curved line of dots that transition in color from blue to red. The dots are arranged in a wave-like pattern, starting with larger blue dots and gradually decreasing in size as they transition to red. ## 4. Device description The subject device Juno VPAP ST-A retains all the same hardware, technologies and manufacturing characteristics as previously cleared in K153061. The device is used in a wider breathing circuit which typically comprises patient tubing and a mask (patient interface) to deliver a prescribed positive airway pressure treatment to patients. Some of the kev features of the device include an in-line power supply: fully integrated humidifier: alarms module; heater controller; colour LCD and simple controls for ease of use. The device also allows data transfer/connectivity via an integrated wireless module (When used in a hospital setting, remote changes may not be appropriate for certain patients, as these setting changes may not be communicated to all hospital personnel treating the patient. Hospital staff should liaise with the patient's regular care provider such that the desired therapy outcome is achieved). Juno VPAP ST-A utilizes a Micro-processor controlled blower system that generates positive airway pressure (CPAP) between 4-20 cmHJO as required to maintain an "air splint" for effective treatment of OSA and (Bilevel) pressures between 3-30 cmH2O for the treatment respiratory insufficiency. The therapy modes available in the Juno VPAP ST-A include CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC and iVAPS. In this subject device now features an optional "AutoEPAP" function on iVAPS mode. AutoEPAP automatically adjusts EPAP pressure (within set values) in response to flow limitations of the upper airway. Juno VPAP ST-A is intended to be used under the conditions and purposes indicated in the labelling provided with the product. It is a prescription device, supplied non-sterile. #### 5. Indications For Use The Juno VPAP ST-A is indicated to provide noninvasive ventilation for patients weighing more than 30lbs (13 kg) with respiratory insufficiency or obstructive sleep apnoea (OSA). The iVAPS mode is indicated for patients weighing more than 66lbs (30 kg). The Juno VPAP ST-A is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for ResMed. The logo features a curved line made up of a series of dots that transition in color from blue to red. Below the line of dots is the word "ResMed" in a bold, sans-serif font. #### Predicate comparison 6. | Characteristics | Juno VPAP ST-A<br>(Subject device) | Juno VPAP ST-A<br>(Predicate device - K153061) | Comments | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | | | | | Indications for use | The Juno VPAP ST-A is<br>indicated to provide<br>noninvasive ventilation for<br>patients weighing more than<br>30lbs (13 kg) with respiratory<br>insufficiency or obstructive<br>sleep apnoea (OSA). | The Juno VPAP ST-A is<br>indicated to provide noninvasive<br>ventilation for patients weighing<br>more than 30lbs (13 kg) with<br>respiratory insufficiency or<br>obstructive sleep apnoea<br>(OSA). | Same intended use - Equivalent | | | The iVAPS mode is indicated<br>for patients weighing more than<br>66lbs (30 kg). | The iVAPS mode is indicated<br>for patients weighing more than<br>66lbs (30 kg). | | | | The Juno VPAP ST-A is<br>intended for home and hospital<br>use. | The Juno VPAP ST-A is<br>intended for home and hospital<br>use. | | | | The Humidifier is intended for<br>single patient use in the home<br>environment and re-use in a<br>hospital/institutional<br>environment | The Humidifier is intended for<br>single patient use in the home<br>environment and re-use in a<br>hospital/institutional<br>environment | | | Environment of use | Hospital/Home | Hospital/Home | Same environment of use - Equivalent | | Prescription status | Prescription only | Prescription only | Same prescription status - Equivalent | | Therapies | | | | | Modes available | • CPAP<br>• S, ST, T<br>• PAC<br>• iVAPS with optional<br>AutoEPAP | • CPAP<br>• S, ST, T<br>• PAC<br>• iVAPS with fixed EPAP only | The subject device includes the same therapy modes<br>as the predicate. An optional "AutoEPAP" function is<br>added on the iVAPS mode. The role of AutoEPAP is to<br>automatically adjust EPAP pressure (within a set min-<br>max range) in order to maintain upper airway patency.<br>Data is provided to demonstrate that the new algorithm | | | | | provides equivalent therapy to set fixed EPAP. | | | | | Equivalent | | Pressure ranges | • 4-20 cmH2O (CPAP)<br>• 3-30 cmH2O (bi-level)<br>o AutoEPAP: 3-25 cmH2O | • 4-20 cmH2O (CPAP)<br>• 3-30 cmH2O (bi-level)<br>o Fixed EPAP: 3-25 cmH2O | The subject device operates within the same pressure<br>ranges as the predicate in all modes. | | | | | On the iVAPS (Bi-level mode), the range of adjustment<br>for the new AutoEPAP feature is the same as with fixed<br>EPAP, hence the same as the predicate. | | | | | Equivalent | | Ramp settings | • User selected as “Off” to 45<br>minutes in 5 minute<br>increments<br>• Max Ramp time set at<br>clinician's discretion | • User selected as “Off” to 45<br>minutes in 5 minute<br>increments<br>• Max Ramp time set at<br>clinician's discretion | Same ramp settings - Equivalent | | Features | | | | | Alarms module | Yes | Yes | Same integrated alarms module - Equivalent | | Humidifier | Yes | Yes | Same integrated humidifier - Equivalent | | Motor type | Brush-less low voltage DC | Brush-less low voltage DC | Same motor - Equivalent | | Operating system | Microchip STM32F405ZG<br>micro-controller with ARM32-bit<br>Cortex™-M4 CPU | Microchip STM32F405ZG<br>micro-controller with ARM32-bit<br>Cortex™-M4 CPU | Same operating system - Equivalent | | Supplemental oxygen | Labeled for use with<br>Supplemental Oxygen | Labeled for use with<br>Supplemental Oxygen | Same use with supplemental oxygen - Equivalent | | Data transfer medium | • SD Card<br>• Fully integrated wireless<br>module | • SD Card<br>• Fully integrated wireless<br>module | Same data transfer and connectivity mediums -<br>Equivalent | | Hardware platform | • Gen 10 | • Gen 10 | Same hardware - Equivalent | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for ResMed. The logo features a curved line made up of a series of dots that transition in color from blue to red. Below the line of dots is the word "ResMed" in a bold, sans-serif font. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the ResMed logo. The logo features a curved line made of connected circles that transition in color from blue to red. Below the curved line, the word "ResMed" is written in a bold, sans-serif font. ## 7. Non Clinical data submitted Bench test data is presented to demonstrate that the subject device meets all requirements of the Juno VPAP ST-A System Specification. For the new AutoEPAP algorithm, this includes characterization of the ventilator's response to a breathing machine that simulates patients flow limitations and apnoeas. The Juno VPAP ST-A has also been tested to the relevant FDA consensus standards and other applicable requirements passing all test protocols. The Juno VPAP ST-A with and without the integrated heated humidifier (HumidAir) was designed and tested according to: - . IEC 60601-1:2005+AMD1:2012, Medical electrical equipment - Part 1: General requirements for safety Medical electrical equipment - General requirements for basic safety and essential performance - . IEC 60601-1-2:2014. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests - . IEC 60601-1-8:2006, Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems - IEC 60601-1-11:2010, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment The device complies with the applicable requirements referenced in the FDA quidance documents: - FDA Draft Reviewer Guidance for Ventilators (July 1995) . - FDA Guidance for the Content of Premarket Submissions for Software Contained in ● Medical Devices (May 11, 2005) ## 8. Clinical data Clinical trial data is provided to demonstrate that the added AutoEPAP iVAPS algorithm performed as expected in maintaining upper airway patency in patients with respiratory insufficiency. The data relates to a double-blinded, randomised, crossover study comparing the efficacy of the AutoEPAP iVAPS therapy mode with the fixed EPAP iVAPS mode (as previously used on the predicate). In patients with respiratory insufficiency, the trial demonstrated that therapy with AutoEPAP iVAPS was as efficacious as iVAPS with fixed EPAP in terms of AHI, ODI, SPO2, PtcCO2 and sleep quality. No serious adverse events or complications related to the study device were recorded. ## 9. Substantial Equivalence Conclusion This submission demonstrates that the subject device is substantially equivalent to the predicate Juno VPAP ST-A (K153061).